Glutamatergic medication in the treatment of Obsessive Compulsive Disorder (OCD) and Autism Spectrum Disorder (ASD)

Phase 3

Completed

• Conditions: 10010118; Obsessief Compulsieve Stoornis; Autism Spectrum Disorder and Obsessive Compulsive Disorder

• Registration Number: NL-OMON41943
• Lead Sponsor: Radboudumc, Donders Institute of Brain, Cognition and Behavior

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

ASD and OCD inpatients or outpatients
Age 6 (ASD) or 8 (OCD) untill 17;9 years at initial inclusion
CGI-S score >/<= 4 (moderately ill) at baseline visit

Exclusion Criteria

Body weight < 20kg at baseline (BL)
Contra-indications for memantine, according to the Summary of Product characteristics (SPC)
Subject has a documented allergy, hypersensitivity, or intolerance to memantine
Subject has a lactose intolerance

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints are measures of<br /><br>* Baseline-to-endpoint change in symptoms/scale scores of compulsivity<br /><br>(CY-BOCS Total score),<br /><br>* adverse event rates and profile (spontaneous reporting, structured (short) AE<br /><br>scale, laboratory measures). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Genotypes of single common and rare variants in candidate genes, and also<br /><br>combined genetic variants in whole genes or neurotransmitter systems / gene<br /><br>pathways;<br /><br>Further lab assessments of various proteins in blood plasma.</p><br>